Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

NCT ID: NCT06498570

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-10

Brief Summary

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Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

Detailed Description

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a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.

Conditions

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Cornea Ectasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

Group Type OTHER

Intracorneal rings

Intervention Type DEVICE

The (ICRS), intracorneal rings segments implantation surgery

Interventions

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Intracorneal rings

The (ICRS), intracorneal rings segments implantation surgery

Intervention Type DEVICE

Other Intervention Names

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INTACS

Eligibility Criteria

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Inclusion Criteria

* stable keratoconus.
* corneal cross-linking performed at least 6 months.
* contact lens intolerance
* minimum corneal thickness of 350 μm at the thinnest point (TP)
* mean keratometry (K mean) value less than 59 D

Exclusion Criteria

* any other associated ocular or systemic pathology could affect the vision.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Elshimaa A.Mateen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elshimaa A.Mateen

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-MED-24-05--03PD

Identifier Type: -

Identifier Source: org_study_id

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